GB/T 16294-2010 PDF English
US$155.00 · In stock · Download in 9 secondsGB/T 16294-2010: Test method for settling microbe in clean room (zone) of the pharmaceutical industry Delivery: 9 seconds. True-PDF full-copy in English & invoice will be downloaded + auto-delivered via email. See step-by-step procedureStatus: Valid GB/T 16294: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivery | Name of Chinese Standard | Status |
| GB/T 16294-2010 | English | 155 |
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Test method for settling microbe in clean room (zone) of the pharmaceutical industry
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| GB/T 16294-1996 | English | 319 |
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Test method for settling microbe in clean room (area) of the pharmaceutical industry
| Obsolete |
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GB/T 16294-2010: Test method for settling microbe in clean room (zone) of the pharmaceutical industry
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GBT16294-2010
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 13.040.30
C 30
Replacing GB/T 16294-1996
Test method for settling microbe in clean
room (zone) of the pharmaceutical industry
Issued on. SEPTEMBER 02, 2010
Implemented on. FEBRUARY 01, 2011
Issued by. China Food and Drug Administration
Table of Contents
Foreword... 3
1 Scope... 4
2 Normative references... 4
3 Terms and definitions... 4
4 Test method... 5
5 Test rules... 7
Annex A (normative) Clean room (zone) sampling point layout... 12
Annex B (normative) Sterilization and preparation of culture medium... 14
Annex C (informative) Technical requirements for settling microbe in clean room
(zone)... 16
1 Scope
This Standard specifies the test conditions and test method for setting microbe
in clean room and clean zone of the pharmaceutical industry.
This Standard is applicable to the test of setting microbe in clean room and
clean zone of the pharmaceutical industry, and in sterile room or local air
purification area (including the clean bench), and the verification of the
environment.
2 Normative references
The following documents contain the provisions which, through reference in this
Standard, become the provisions of this Standard. For dated references, their
subsequent amendments (excluding corrigendum) or revisions do not apply to
this Standard. However, the parties who enter into agreement based on this
Standard are encouraged to investigate whether the latest versions of these
documents are applicable. For undated reference documents, the latest
versions apply to this Standard.
GB/T 16292-2010 Test method for airborne particles in clean room(zone) of
the pharmaceutical industry
3 Terms and definitions
For the purpose of this Standard, the following terms and definitions apply.
3.1 settling microbe
Visible number of colonies that are colonized using living microbial particles in
the air collected by the method mentioned in this Standard, in special culture
medium, under suitable growth conditions.
3.2 settling microbe plate count
Number of setting microbe in the air that are collected in each plate petri dish
in the specified period of time, expressed in cells/dish.
4 Test method
4.1 Method summary
This test method adopts the sedimentation method, that is, collect biological
particles in the air on the culture medium plate through natural sedimentation
principle, after some time, let it grow to visible colonies under appropriate
conditions and count, determine the number of living microorganisms in a clean
environment by counting the number of colonies in the plate petri dish, so as to
assess the cleanliness of the clean room (zone).
4.2 Personnel responsibility and training
The test personnel of the clean room (zone) shall be trained in this specialty
and obtain relevant qualifications before they can perform their duties in the
clean room (zone) test, which includes hygienic knowledge and basic
knowledge of the microorganisms involved.
4.3 Instruments
The instrument shall include.
4.3.1 Petri dish
It generally uses φ90 mm × 15 mm petri dishes.
4.3.2 Culture medium
Soybean casein agar medium (TSA) or sabouraud medium (SDA) or user-
approved and validated medium. The preparation method is shown in Annex B.
4.3.3 Constant temperature incubator
The constant temperature incubator must be checked regularly.
4.4 Test procedure
4.4.1 Before test, the surface of the petri dish must be strictly sterilized.
4.4.2 PLACE the prepared petri dishes one by one according to the sampling
point layout, and then OPEN the lid of the petri dishes one by one from inside
to outside so that the surface of the culture medium is exposed to air.
4.4.3 In the static state test, the exposure time of the petri dishes is more than
30 min; in the dynamic state test, the exposure time of the petri dishes is not
more than 4 h.
4.4.4 After all sampling is complete, place the petri dishes in the constant
temperature incubator.
4.4.5 The petri dish prepared by soybean casein agar medium (TSA) are
sampled and cultured in the incubator at 30 °C to 35 °C for no less than 2 d.
The petri dish prepared by sabouraud medium (SDA) are sampled and cultured
in the incubator at 20 °C ~ 25 °C for no less than 5 d.
4.4.6 Each batch of culture medium shall have a control test to test whether the
culture medium itself is contaminated. It may select three petri dishes for control
culture in each batch.
4.5 Colony count
4.5.1 Directly count and mark all the colonies on the petri dish with the naked
eye or count on the colony counter, and then check with a magnifying glass 5
to 10 times for omission.
4.5.2 If there are 2 or more colonies overlapping on the plate, it will still count
as 2 or more colonies when they are distinguishable.
4.6 Precautions
4.6.1 The test instruments shall be sterilized to ensure the reliability and correctness of the test.
4.6.2 Take all measures to prevent human contamination of the sample.
4.6.3 Make a detailed record of the culture medium, culture conditions and other parameters.
5 Test rules
5.1 Test conditions
Before test, the clean room (zone)-related parameters shall be pre-tested,
which will provide environmental conditions for testing setting microbe. For
example, the pre-test may include.
5.2 Test states
Both static and dynamic states can be tested.
In the static state test, the number of indoor testing personnel shall not be more than 2.
Before the settling microbe test, is decided by the user whether or not the clean
room (zone) to be tested needs to be disinfected in advance.
The test report shall indicate the state used and the number of indoor testing
personnel during the test.
5.3 Test time
5.3.1 In the empty state or static state a test, for unidirectional-flow clean rooms
(zones), the test should be started after the clean air conditioning system is
normally operating for not less than 10 min. For non-unidirectional-flow clean
rooms (zones), the test should start after the clean air conditioning system is
normally operating for not less than 30 min. In the static b test, for unidirectional-
flow clean rooms (zones), the test should be started after the production
operators are evacuated from the site and after 10 min self-cleaning; for non-
unidirectional-flow clean rooms (zones), the test should be started after the
production operators are evacuated from the site and after 20 min self-cleaning.
5.3.2 In the dynamic state test, it shall record the production start time and test time.
5.4 Calculation of settling microbe plate count
5.4.1 Number of sampling points and their layout
5.4.1.1 Minimum number of sampling points
The minimum number of sampling points for the settling microbe test may refer
to GB/T 16292-2010.
5.4.1.2 Position of sampling points
The position of sampling points for setting microbe may refer to GB/T 16292- 2010.
5.4.2 Minimum number of petri dishes
While satisfying the minimum number of sampling points, it should satisfy the
minimum number of petri dishes, as shown in Table 1.
5.4.3 Number of sampling
Each sampling point is generally sampled once.
5.4.4 Precautions of sampling
5.4.4.1 For unidirectional-flow clean rooms (zones) or air supply ports, the
sampling port of the sampler shall face the airflow direction; for non-
unidirectional-flow clean rooms (zones), the sampling port shall be upward.
5.5 Records
The test report shall contain the following.
5.6 Result calculation
5.6.1 Count the number of colonies in each petri dish.
5.6.2 For the calculation of the average colony count of setting microbe at each
test point, see equation (1).
5.7 Result evaluation
5.7.1 The average colony number of setting microbe at each test point must be
lower than the limit in the selected evaluation criteria.
5.7.2 In the static state test, if the average colony number of setting microbe at
a certain test point exceeds the evaluation criteria, it shall re-sample twice. It is
determined qualified only when the two test results are qualified.
5.8 Daily monitoring
For monitoring of setting microbe, it should set correcting limits and warning
limits, to ensure that the microbial concentration in the clean room (zone) is
controlled. It shall carry out periodic test to check the microbial load and the
effectiveness of the disinfectant to perform propensity analysis. Both static and
dynamic monitoring can use this method.
For the sampling frequency of setting microbe, it shall be considered for
modification if the following conditions occur. After evaluating the following
conditions, it shall also determine the test frequency of other items.
- continuously exceeding correcting limits and warning limits;
- the duration of downtime is longer than expected;
- the presence of contamination in key areas;
- during the production, the air purification system performs any major
maintenance;
Annex A
(normative)
Clean room (zone) sampling point layout
A.1 The clean room (zone) sampling point layout should be uniform, avoiding
sampling points being too sparse in local areas. The following sampling point
layout diagram of multi-point sampling may be used as reference (see Figure A.1).
A.2 The sampling points of class 100 unidirectional-flow zone, clean bench or
local air purification facilities should be located on the working surface facing
the direction of the air flow. The air flow pattern may refer to Figure A.2 and
Figure A.3.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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